Tryptic Soy Broth, Non-Animal Origin, Irradiated


Cat. No. 1.00550.5007
 (5 kg)


Medium used for the sterility testing of pharmaceutica products and te microbiological validation of aseptic filling lines (Media Fill Test).


The medium contains no material from animal origin and during processing it did not come in contact with any substance derived from animal material. Additionally, the medium is sterilized by gamma irradiation (48-62kGy) to guarantee absence of bacteria, spores, viruses, Mycoplasma, and Hepes cells. The QC test for sterility is carried out in compliance with European Pharmacopoeia and the United States Pharmacopoeia.

Mode of Action Experimental Procedure and Evaluation
Typical Composition (g/liter) Quality Control
Preparation Literature


Mode of Action
 The medium complies with the recommendations of USP XXVII (2004), EP (1999), and the PhEur (1999) German Edition.

The microbiological performance of Tryptic Soy Broth non-animal origin (irradiated) is equivalent to the regular Tryptic Soy Broth.

Typical Composition (g/liter)
 Peptone, non-animal origin 20.0; D(+)-glucose 2.5; sodium chloride 5.0; di-potassium hydrogen phosphate 2.5.

Preparation
 Suspend 30.0 g in 1 liter sterile purified water. Gently shake for complete dissolution and use according to the required application.

pH: 7.3 + 0.2 at 25°C.

The prepared medium is clear and yellowish-brown.

Experimental Procedure and Evaluation
The medium is very suitable for the simulation of aseptic filling of sterile powder. The filled powder is readily soluble in sterile purified water and can be dissolved directly together with the filled units. The aseptically prepared nutrient medium can be used for the simulation of the aseptic filling of liquids. Bacteria should demonstrate good growth after 3 days of incubation at the latest and yeasts and molds after 5 days.

Quality control

Test strains
 Growth
 Maximum Incubation Time
Escherichia coli ATCC 8739
 		+
 		3 days
Staphylococcus aureus ATCC 6538-P
 +
 3 days
Streptococcus pneumoniae ATCC 6301
 +
 3 days
Bacillus subtilis ATCC 6633
 +
 3 days
Pseudomonas aeruginosa ATCC 9027
 +
 3 days
Candida albicans ATCC 10231
 +
 3 days
Candida albicans ATCC 2091
 +
 3 days
Aspergillus niger ATCC 16404
 +
 3 days


Sterility test acc. to USP guidelines (2 weeks at 20-25°C and 30-35°C): no turbidity, no growth.



Literature

Product Brochure

 Deutsches Arzneibuch, 10. Auflage
 European Pharmacopeia II (1999).
 United States Pharmacopoeia XXVII (2004).
 ISO 13408-1, 1998-08-00, Aseptic Processing of health care products - Part 1: General Requirements.




© 2002 Merck KGaA, Darmstadt, Germany